Associate III, Regulatory Affairs

Job Description

2023 will potentially see Sandoz become a standalone organization! Already a global market leader in Generics and Biosimilar medicine, this is an exciting, once-in-a-career opportunity to set our own path forward as an independent, purpose-driven organization, and as the founders of a new Sandoz, this is a time of immense opportunity for us all, both professionally and personally!

Together we will shape the future of Sandoz...are you ready to make a difference?

As the Associate III, Regulatory Affairs, you will be responsible for preparing and submitting regulatory filing documents in collaboration with internal business partners and stakeholders in order to obtain documentation required for submissions.

Your additional responsibilities include, but not limited to:
•Independently review and compile ANDAs, Amendments, Supplements, Annual Reports, etc. for FDA submissions in eCTD format as per FDA regulations and guidelines
•Review Labeling Change Control requests and approve revised labeling documents, which may include physician and patient package inserts as well as various types of container labels
•Effectively monitor and track information and requirement changes
•Evaluate, review, and maintain process change controls to communicate regulatory submission strategies and acquire necessary and compliant documentation
•Interact with regulatory agencies as business needs require
•Maintain compliance with regulatory requirements and regulatory databases for generic drugs for the US market.
•Adhere to all health, safety & environmental (HSE) requirements in support of departmental and site HSE goals

Diversity & Inclusion / EEO

The Novartis Group of Companies are Equal Opportunity Employers and take pride in maintaining a diverse environment. We do not discriminate in recruitment, hiring, training, promotion or other employment practices for reasons of race, color, religion, gender, national origin, age, sexual orientation, gender identity or expression, marital or veteran status, disability, or any other legally protected status. We are committed to building diverse teams, representative of the patients and communities we serve, and we strive to create an inclusive workplace that cultivates bold innovation through collaboration and empowers our people to unleash their full potential.

Minimum Requirements

What you’ll bring to the role:
•Bachelor’s Degree in a scientific related field is preferred, with 1-3 years regulatory experience. Associate degree is acceptable with minimum 5 years regulatory experience
• Fluent in written and spoken English.
• Excellent oral and written communication skills

Desirable:
• Pharmaceutical or generic drug experience in a regulatory capacity
• Lab experience and familiarity with Abbreviated New Drug Application (ANDA) and/or Electronic Common Technical Document (eCTD)

This opportunity is located at the Sandoz Princeton, NJ site, and will not have the ability to be located remotely. Preference will be given to local candidates not requiring relocation.

Commitment to Diversity & Inclusion:
Sandoz is committed to building an outstanding, inclusive work environment and diverse teams representative of the patients and communities we serve.

Accessibility and Reasonable Accommodations:
Individuals in need of a reasonable accommodation due to a medical condition or disability for any part of the application process, or to perform the essential functions of a position, please send an e-mail to [email protected] or call +1 (877)395-2339 and let us know the nature of your request and your contact information. Please include the job requisition number in your message.

The pay range for this position at commencement of employment is expected to be between $97,600 and $146,400/year; however, while salary ranges are effective from 1/1/23 through 12/31/23, fluctuations in the job market may necessitate adjustments to pay ranges during this period. Further, final pay determinations will depend on various factors, including, but not limited to geographical location, experience level, knowledge, skills and abilities. The total compensation package for this position may also include other elements, including a sign-on bonus, restricted stock units, and discretionary awards in addition to a full range of medical, financial, and/or other benefits (including 401(k) eligibility and various paid time off benefits, such as vacation, sick time, and parental leave), dependent on the position offered. Details of participation in these benefit plans will be provided if an employee receives an offer of employment. If hired, employee will be in an “at-will position” and the Company reserves the right to modify base salary (as well as any other discretionary payment or compensation program) at any time, including for reasons related to individual performance, Company or individual department/team performance, and market factors.

Why Sandoz?
Almost 500 million patients were touched by Sandoz generic and biosimilar medicines in 2022 and while we’re proud of this, we know there is more we could do to continue to help pioneer access to medicines for people around the world.

We are at a pivotal moment in our history giving us the freedom to invest in our future so we can continue to help millions of people access affordable high-quality medicines. Together we will shape the future of Sandoz, building an organization from the ground up and in return, experience an ambitious environment with impactful, flexible-hybrid careers, where diversity is welcomed and where personal growth is encouraged!

The future is ours to shape!

If this role is not suitable to your experience or career goals but you wish to stay connected to hear more about Sandoz and our career opportunities, join the Network here: https://talentnetwork.novartis.com/sandoztalentpool .